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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02428335
Study of Muscle Energy Metabolism in RCC Patients Treated With Sunitinib
2 de julio de 2019 actualizado por: AHS Cancer Control Alberta
Evaluation of Technetium-99m Sestamibi to Determine Muscle Energy Metabolism in RCC (Renal Cell Cancer) Patients Treated With Sunitinib
Sunitinib is a chemotherapy approved by the FDA as a standard of care treatment for renal cell carcinoma (RCC).
Fatigue is a very common side effect of sunitinib that frequently causes dose reductions.
The cause of this fatigue remains unclear.
This study will use a special type of scan to study sunitinib-induced fatigue in relation to exercise.
Descripción general del estudio
Estado
Retirado
Condiciones
Descripción detallada
Sunitinib, a type of tyrosine kinase inhibitor (TKI) has been approved by the FDA as a standard of care treatment for renal cell carcinoma (RCC).
Fatigue is a very common side effect of sunitinib that frequently causes dose reductions.
The cause of this fatigue remains unclear.
It has been shown that TKIs disrupt growth factor pathways in muscles leading to muscle shrinkage.
If sunitinib associated fatigue is due to altered muscle physiology at a molecular level, there will be observable changes in the uptake of 99mTc-sestamibi in scintigraphy scans.
The study objective is to determine if sunitinib-induced fatigue as determined by VO2 and QOL fatigue related questionnaire responses are correlated to molecular changes in the muscles as evidenced by 99mTc-sestamibi uptake.
Tipo de estudio
De observación
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alberta
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Men and women aged 18 years of age or older with a confirmed diagnosis of renal cell carcinoma.
Participants will receive standard of care treatment with sunitinib.
Participants must be willing to undergo exercise testing and diagnostic imaging with technitium 99m-sestamibi
Descripción
Inclusion Criteria:
- Signed informed consent before any study procedures completed
- Patients must have histologically or cytologically confirmed RCC.
- Four weeks must have elapsed since prior chemotherapy, hormonal therapy, targeted therapy or radiation therapy. There is no restriction on the amount of bone marrow previously radiated.
- Recovery to baseline or, at most, grade 1 of all drug-related toxicities due to prior chemotherapy, radiation, hormonal therapy, or molecular targeted therapy, expect for alopecia.
- Male / female subject ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of <2 (Karnofsky >70%)
- Life expectancy of at least 12 weeks
Normal organ and marrow function as defined by :
- absolute neutrophil count (ANC) > 1500/mcL
- hemoglobin (Hb) > 90 g/L
- platelet count ≥ 1000.000/mcL,
- total bilirubin ≤ 1.5 x the upper limit of normal range (ULN)
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (<5 x ULN presence of liver metastases)
- creatinine < 1.5 x institutional ULN
- Cardiac ejection fraction by MUGA scan or echocardiogram must be >50% for patients at baseline.
- Ability to understand the purpose of the study and the willingness to sign a written informed consent document
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Standard Nuclear Medicine department pregnancy screening will be conducted prior to each 99mTc-sestamibi scan. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. The investigator is requested to advise the patient how to achieve an adequate contraception.
- Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
Exclusion Criteria:
- Patients who have had chemotherapy, hormonal therapy, molecular targeted therapy, or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents.
- Prior treatment with a drug with known anti-angiogenic properties, including other tyrosine kinase inhibitors to VEGFR
- Any psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, HIV, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients that are on therapeutic dose of coumadin or an INR of 1.5 c ULN. Patients that are on low dose coumadin (2mg or less for patency of the central venous catheter) or therapeutic dose of low molecular weight heparin will be allowed.
- Patients who cannot swallow
- Patients who are breast-feeding.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
99mTc-sestamibi uptake in muscle cells
Periodo de tiempo: 12 weeks from start of treatment
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12 weeks from start of treatment
|
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99mTc-sestamibi uptake in muscle cells
Periodo de tiempo: 24 weeks from start of treatment
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24 weeks from start of treatment
|
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99mTc-sestamibi uptake in muscle cells
Periodo de tiempo: 36 weeks from start of treatment
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36 weeks from start of treatment
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of sunitinib related fatigue
Periodo de tiempo: 36 weeks after the start of sunitinib treatment
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36 weeks after the start of sunitinib treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michael Sawyer, MD, Alberta Health Services
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2015
Finalización primaria (Actual)
18 de marzo de 2019
Finalización del estudio (Actual)
18 de marzo de 2019
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2015
Publicado por primera vez (Estimar)
28 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
2 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Sestamibi 1.0
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .